Edwards EVOQUE Stabilizer 9850SZUS

GUDID 00690103219579

Edwards EVOQUE Stabilizer

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00690103219579
• NIH Device Record Key: 49ee47a0-5883-47f5-bc2d-3b211e104b03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards EVOQUE Stabilizer
• Version Model Number: 9850SZUS
• Catalog Number: 9850SZUS
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103219579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230013

FDA Product Code

• QWA: Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-17
• Device Publish Date: 2025-07-09

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019261 - HEART VALVE SIZER ACCESSORY: 2026-02-18 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103186307 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MGNA MITRAL EASE REPLICA SIZER
• 00690103186314 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186321 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186338 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186345 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186352 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186369 - BARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER